OL Pr ms RA isc CNAS Be NS a _ et) Tost Report suszozsza4azaaosTx May 19,2020 Pago 1 of 8 ZHEJIANG HONGYU MEDICAL COMMODITY CO, LTD NO.868 CHANHUA ROAD FOTANG TOWN INDUSTRIAL FUNCTIONAL AREA 322002 YIWU CITY, ZHEJIANG PROVINCE, PEOPLE'S REPUBLIC OF CHINA The following sample(s) washwere submitted and identified on behalf ofthe client as: ‘Sample Description (A)Protective Mask 'SGS Internal Ret No. ‘SHHL2004510015MD Style No Folded ‘Sample Color caywite Item No. HYo01 Manufacturer ZHEJIANG HONGYU MEDICAL COMMODITY CO., LTD ‘Supplier ZHEJIANG HONGYU MEDICAL COMMODITY CO., LTD Request Age Grading 3 Years Test Performed Selected test(s) as requested by applicant ‘Sample Receiving Date: Apr 08, 2020 Testing Period ‘Apr 08, 2020 - May 19, 2020 Test Result(s) Unless otherwise stated the results shown inthis test report refer only to the ‘sample(s) tested, fr further details, please refer to the following page(s). Conclusior ‘Sample No. A) ‘No recommendation Signed for and on behatf of SGS-CSTC Standards Technical Services (Shanghai) Co., Ltd Testing Center bre (rev Sara Guo (Account Executive) eeayeas reeznsesmes —— mmupgansene thecteaces teciecens —eamomawen Member tha 895 Grow (S08 A)Test Report $L2025244324401TX Date:May 19,2020 Page 2 of 9 Tost Result ratory Protective Devices. Testing, Marking, (EN 149:2001+A1:2009) Glause 7.4 Packaging (EN 149:2001+A1:2009 Clause 8.2) Particle fitering half masks shall be offered for sale packaged in such a way that they are protected against mechanical damage and contamination Comply Pass before use. Glause 7.5 Materials (EN 149:2001+A1:2009, Clause 8.2 & 8.3.1 & 8.3.2) ‘Materials used shall be sutable to withstand handling and wear over the ‘Comply ppetiod for which the particle fitering half mask is designed to be used. ‘Afler undergoing the conditioning described in 8.3.1 none of the particle filtering half masks shall have suffered mechanical failure of the facepiece Comply or straps. Pass ‘When conditioned in accordance with &3.1 and € 3.2 the paricle fitering Comply half mask shall not collapse. ‘Any material from the fiter media released by the ai flow through the fiter ‘Comply shall not constitute a hazard or nuisance for the wearer, 7.6 Cleaning and Disinfectingit (EN 149:2001+1:2009, Clause 8.4 & 858 8.11) ifthe particle ftering half mask is designed to be re-usable, the materials sed shall withstand the cleaning and disinfecting agents and procedures to Not applicable be specified by the manufacturer. ith reference after cleaning and disinfecting the re-usable particle | (Notdesignedto | NA With reference to 7.9.2, after cleaning and disinfecting th he particle | eee fitering haif mask shall satisty the penetration requirement ofthe relevant class, Clause 7,7 Practi form: (EN 149:2001+A1:2008, Clause 6.4) The parte fitering half mask shall undergo practical performance tests under realistic conditions. These general tests serve the purpose of checking the equipment for imperfections that cannot be determined by the tests described elsewhere in this standard. No imperfections | Pass Gavcm acs TO NAM OZISARENS wrung mes See ACaMuMaoRee wa men — teez}cm ezieeu + mmdeson amber ofthe S05 Group ($08.84)Test Report $L2025244324401TX Date:May 19,2020 Clause 7.8 Finish of Parts Page 3 of 9 (EN 149:2001+1:2009, Clause 8.2) Paris ofthe device likely to come into contact withthe wearer shallhave no | Nosharp edges | pase sharp edges or burs, ‘or burrs Clause 7.9.1 Total Inward Leakago# (EN 149:2007+A1:2009, Clause 6.5) The tolal inward leakage consists of three components: face seal leakage, exhalation value leakaget(f exhalation value fited) and fiter penetration, For particle fitering half masks fitted in accordance with the manufacturer's information, at least 46 out of the 50 individual exercise results (ie. 10 subjects x 5 exercises) for total inward leakage shall be not greater than: Detal refer to 25% for FFP1, 11% for FFP2, 5% for FFP3 ‘Appendix 1 ‘and, in addition, atleast 8 out of the 10 individual wearer arithmetic means for the total inward leakage shall be not greater than: 22% for FFP1, 8% for FFP2, 2% for FFP3 ‘Appendix 1: Summarization of Test Data {Dalia Subject | Sample | Condition | Waik(%) | Head Head | Taik(%) | Walk(®) | Mean(%) No. Side/side(%) |_upidown(%) Yi 4 AR | 747 7.04 774 753 | 774 75 Gong [2 AR | 707 744 718 725 | 7.43 73 Yu. 3 AR | 7.412 757 7.35 722 [729 | 73 Hu. 4 AR | 7a 786 778 7707.69 77, Xu, 5 AR | 723 762 733 743 [7.46 | 74 Deng [6 TC. [775 728 792. rai | 7.01 76 Zhang [7 Tc. [7.28 7.63 7.45. 782_| 766 | 75 Zhi @ Tc. | 756 7.03 7.58. 789 [7.60 75 Fang | 9. Tc. 7.68, 7.69 797, 7.93_|_770_| 78 Ww 10 Tc. 7.96 7.34 743 7.99 | 722 76 ‘SQout of 0 individual exercise results were not greater than 11 % ae ‘out of 10 individual wearer arithmetic means were not greater than_8 % Facial Dimension Subject Face length Face With Face Depth Mouth Width Yi 120 130 108 5a Gong 422 140 115 55, Yu 119 160 139 55. Hu 112 122 119 63 Xu, 110 130 118 60. Deng 115 118 110 59 Zhang 112 123 113 55, Liu 103 130 100 50. teense teeanecm pene ee Teoma amber ofthe S05 Group ($08.84)Test Report $L52025244324401TX Date:May 19,2020 Page 4 of 9 85 Za 118 139 130 Fang 115 129 120 50, (Chen 116 150 132 56. lv 110 121 110 Ed Penetration of Filtor Matorialit (EN 149:2001+A1:2009, Clause 8.11 & EN 13274-7:2019) The penetration of the fiter ofthe particle fitering half mask shall meet the requirements ofthe following table. Classifica Maximum penetration af est aerosol tion | Sodium chionée test 95 Parafin of test 95 Umnin min Detail eter to mae mee ‘Appendix 2 Mad FRB 20 20 FFP? 6 6 FES o + ‘Appendix 2: Summarization of Test Data Penetration of fier material ‘Aerosol Condition ‘Sample No. mae Assessment i 3.15 As received 12 3.46 13 332 14 4.16 Sodium chloride test | Simulated wearing treatment 15 325 16 437 ‘Mechanica strength + Temperature 4 a8 conditioned 2 48 20 347 Pass As received 21 3.42 2 446 23 449 Paraffin ol test Simulated wearing treatment 24 427, 25 435 26 426 ‘Mechanical stength + Temperature 38 438 conditioned 2 aus Flow conditioning: Single fiter: 95.0 Limin Teeaneees erzj6e8N erga mms esate I eezieeu Smads amber ofthe S05 Group ($08.84)Test Report $L2025244324401TX Date:May 19,2020 Page 5 of 9 with Skint 109, Clause 8.4 & 8.5) re ied tice Materials that may come info contact wih the wearers skin shal not be | _ Notation or known to be likely to cause ition or any ther adverse efecttoheatth. | anyother adverse | Pass fect to health Clause 7.14 Flammabitiyt (EN149:2007+AT 2009, Cause 6.) The material uses shal not present a danger for the wearer and shal not be of high flammable nature Detaileferto | pags When tested, the particle itering ha mask shall nt bum ornat to continue | Appendix 3 to bur for more than 5s after removal fom the lame ‘Appendix 3: Summarization of Test Data ammabi ‘Condition Sample No. Result Assessment 2 Bum for Ts As received 2 Bumiorts - | Temperate [st Bumfor?s| conditioned 32 Bumfor's {eN'149:2001+AT 2000, Clause 6.7) Te carbon dioxide content of te inhalation a (dead space) shall not Detail eferto | agg exceed an average of 1.0% (by volume) Appendix 4 Appondic 4: Summarization of Test Data (Catbon Dioxide Content of The Inhalation Ai Condition | Same No Reaut Haseena 33 0a As received 34 Oat% Mean value 0.4% Pass 35 Ott Clause 7.13 Hoad Hamess# (EN149:2007+AT-2009, Clause 8.4 & 8.5) The head harness salle designed so tha he patil fitenng na mask can be donned and removed eas ‘The head harness shallbe adjustable oF seiFadjustng and shal be Pass ‘sufficiently robust to hold the particle filtering half mask firmly in position and be capable of maintaining toal inward leakage requirement forthe devi. eee ietrcm acs TNA SES Sere ACRNuMeORNe wa men — teEz}om |e 2ieD satseanre oer amber ofthe S05 Group ($08.84)Test Report $L2025244324401TX Date:May 19,2020 Clause 7.14 Field of Visions (EN 149:2001+A1:2009, Clause 8.4) The feld of vision is acoeplable i determined so In practical performance tests ‘Comply Page 6 of 9 Pass Glause 7.15 Exhalation Valve(si# (EN 149:2001+A1:2009, Clause 6.2 8.9.1 £8.34 &8.8) (@)A particle fitering half mask may have ane or more exhalation valve(s), hich shail function correctly in all orientations. ‘Not applicable due to No exhalation valve (b)Ifan exhalation vaive is provided it shal be protected against or be withstand axially a tensile force of 10N applied for 10 s. Fesistantto ait and mechanical damage and may be shrouded of may aeeisrea include any other device that may be necessary for the particle filtering half | 6 iStion valve. ab eo OT (©) Balaton valves) ited hel coninue io operate corecty aera | Notappieale Grinuovs etalon fof S00 Inn over 8 peru of 908 apie (@)When he exralaton valve housing i atached ome facebianktsnat_| Not appieabe exhalation valve Glauso 7.16 Breathing Resistance#t (EN 149:2001+A1:2009, Clause 6 8) ‘The penetration of the fiter ofthe particle fitering half mask shall meet the requirements ofthe folowing table. ‘Classification Maximum permitted resistance (mbar) Inhalation Exhalation 30 min ‘5 Umin 60min FFPI 08 2A 30) FFP2 O7, 24 30) FFP3 10 3.0 30, Seat cream mi omicadecbupne zon 1BeAINH | BRED Sere ACRNuMeORNe wa men — teEz}om |e 2ieD Detail refer to ‘Appendix 5 Teoma amber ofthe S05 Group ($08.84)Test Report $L2025244324401TX Date:May 19,2020 Page 7 of 9 ‘Appondix : Summarization of Test Data Breathing resistance (mba 3 perme ATB[ CIDE DIE As received 30umin [os [os] oa] «| oa 03/04) Inhalation |~g5 timin [12 | 13] +4] 13] #3 14) 42 Exhalation | 160 Umin_[s4[ 15] sa] 14] v4 tal 44 Simulated Eee CTD D wearing ‘aoumin [os [os os] os| oa 03| 03] treatment | !Mhalation | ~ 95 tmin—[as[ s4[ 13] 13/13 ta] 43 Exhalation | 160 Umin_[ 15) 18] 16] 17) 14 16) 47 Flow rate 2 a eae AT BI CIDE DIE ‘BOumin [os [os] os] 03] o« os] om conditioned | Inhalation | 95 timin [14] 13] v4] ve] 12. 12) 13 Exhalation | 160 Umin_[+5) 15] sa] v4] va ta) 4 Assessment Pass A: facing directly ahead: B: facing vertically upwards; C: facing vertically downwards; D: lying on the left side; E: lying on the right side Clause 7.17 Clogging (EN 149:2007+A1:2009, Clause 8.9 & 8.10) (Clause 7.17.2 Breathing resistance Valved particle fitering half masks: After clogging the inhalation resistances shall nt exceed FFP1: 4 mbar, FFP2: § mbar, FFP3: 7 mbar at 95L/min continuous flow ‘The exhalation resistance shall not exceed 3 mbar at 160 Limin continuous | Optional for single flow. shift device only NA Val cle fitering halt m [After clogging the inhalation and exhalation resistances shall not exceed: FEP1: 3 mbar, FEP2: 4 mbar, FFP3: 5 mbar at 95L/min continuous flow re ied tice ovis Salat 2 suemesemiaes oe Teeaneees erzj6e8N erga mms See ACaMuMaoRee wa men — teez}cm ezieeu + mmdeson amber ofthe S05 Group ($08.84)Test Report $L52025244324401TX Date:May Page 8 of 9 7.17.3 Penetration of fter material Alltypes (valved and valveless) of paricle fitering half masks claimed to ‘meet the clogging requirement shall also meet the requirements. Ciasaificatio Maximum penetration of test aerosol n Sodium chiorde test 95 Vin | Parafin oll test 95 Umin | | Optional for single | 4. % % ‘shift device only max. Tax, FFPI 20 20 FFP2 6 6 FFP 1 1 Glause 7.18 Demountable Parts, (EN 149:2001+A1:2009, Clause 6.2) ‘All demountable parts (if fed) shall be readily connected and secured, No demountable | yq, where possible by hand parts Test Uncertainty Total inward leakage 41% Penetration of fiter material, 1.1% Flammability 5.0% ‘Carbon dioxide content ofthe inhalation air] 2.63% Breathing resistance 1.8% # This test standard is not within the accredited scope in SGS Shanghai testing centro, itis carried out by external laboratory accredited by CNAS (China National Accreditation Service for Conformity ‘Assossmont) 1499. re ied tice m Sassen vo Tien etns 1 pe oORE eMac SHER MCEMUMAONS wm. 2u —IOEENEAKI eEejeeBMN —¢ sncBanon amber ofthe S05 Group ($08.84)Test Report $L2025244324401TX Date:May 19,2020 Page 9 of 9 Sample Photo ‘The statement of conformity inthis test report is only based on measured values by the laboratory and does not take their uncertainties into consideration, "End of Report'** amber ofthe S05 Group ($08.84)